Monovisc

GUDID 05060604130065

ACRE PHARMA LIMITED

Synovial fluid supplementation medium

• Primary Device ID: 05060604130065
• NIH Device Record Key: 97e4022b-de4d-446f-8d39-e72d2b4e985d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monovisc
• Version Model Number: N/A
• Company DUNS: 218668297
• Company Name: ACRE PHARMA LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store Monovisc in its original package at room temperature (below 77 degrees F/25 degrees C). DO NOT FREEZE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060604130065 [Primary]

FDA Product Code

• MOZ: Acid, Hyaluronic, Intraarticular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-14
• Device Publish Date: 2019-01-14

Devices Manufactured by ACRE PHARMA LIMITED

• 05060604130065 - Monovisc: 2019-02-14
• 05060604130065 - Monovisc: 2019-02-14
• 05060604130041 - Synvisc: 2018-08-27
• 05060604130034 - Synvisc One: 2018-07-27 Inject into the knee to relieve the pain from osteoarthritis.
• 05060604130003 - Euflexxa: 2018-05-28 Injected into the knee to relieve the pain from osteoarthritis.
• 05060604130010 - Orthovisc: 2018-05-28 Inject into the knee to relieve the pain caused by osteoarthritis.
• 05060604130027 - Supartz: 2018-05-28 Injected into the knee to relieve the pain from osteoarthritis.